BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR
FDA premarket approval P010062/S003 · decided 2006-02-21
Approval details
- PMA number
- P010062
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Bausch & Lomb
- Date received
- 2005-04-18
- Decision date
- 2006-02-21
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL OF REVISIONS TO THE POST-APPROVAL REGRESSION ANALYSIS PROTOCOL.
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